Prosthesis DurabilityNCT06040385
Effect of Geometric Modifications of Implant Scan Bodies
A study testing Implant supported hybrid prosthesis in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this clinical study will be the effect of geometric modifications of implant scan bodies compared to conventional transfer techniques on passivity of all on four mandibular restorations Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Durability
- What is being tested?
- Implant supported hybrid prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2023to 16 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. All selected patients will have four implants placed in the mandibular interforaminal region according to all -on -four concept.
- 2. All selected patients have a healthy mucosa and with no clinical complications.
- 3. All patients are cooperative and approve the proposed treatment protocol.
Who cannot join
- 1. Patients who reject to participate in the study. 2. Patients who need implant placement as a result of previous implant failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Geometric Modifications of Implant Scan Bodies Compared to Conventional Transfer Techniques on Passivity of Mandibular All on Four Restorations
The aim of this clinical study will be the effect of geometric modifications of implant scan bodies compared to conventional transfer techniques on passivity of all on four mandibular restorations
Read the detailed description
The aim of this study will be the effect of geometric modifications of implant scan bodies compared to conventional transfer techniques on passivity of all on four mandibular restorations.
Evaluation method:
The trueness of the final impression and the passivity of the final prosthesis will be evaluated by two methods:
Invitro evaluation For each patient in every group, the standard tessellation language (STL) files of scanned impressions will be superimposed on the reference file to determine the 3D surface, linear, and angular position analysis.
The STL files for both frameworks will be superimposed on the reference file to determine the passivity.
In vivo (Clinical) evaluation Radiographic evaluation using long cone parallel technique will be done for the framework after 6 month (T6) after one year (T12), and after 18 month (T18) from insertion.
- Conditions
- Prosthesis Durability
- Being tested
- Implant supported hybrid prosthesis
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant supported hybrid prosthesisDevice
For each patient, implant supported mandibular hybrid prosthesis will be fabricated digitally. Frameworks will be tried in patient's mouth, scanned intraorally by intraoral scanner (IOS).
| Study group | Role | What they receive |
|---|---|---|
| • Group I (control group) | Active comparator | Final impression will be done by conventional one-step impression technique. For the same patient, another final impression using unmodified scan bodies will be done by direct intraoral scan technique. Receives: Device: Implant supported hybrid prosthesis |
| • Group II (Test Group) | Active comparator | Final impression will be done by conventional one-step impression technique. For the same patient another final impression using subtractive modified scan bodies will be done by direct intraoral scan technique Receives: Device: Implant supported hybrid prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
passivity of the prosthesis
Radiographic evaluation using long cone parallel technique will be done for the framework
Measured: one year
trueness of final impressions
For each patient in every group, the standard tessellation language (STL) files of scanned impressions will be superimposed on the reference file to determine the 3D surface, linear, and angular position analysis
Measured: one year
Secondary outcomes (1)
patient satisfaction
patient satisfaction will be evaluated using Visual analogue scale questionnaire
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start20 Mar 2023
- Primary completion7 May 2024
- Study completion16 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis DurabilityStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For group (I): For each patient, two final impressions will be made a) Final impression will be done by conventional one-step impression technique.For the same patient, another final impression using unmodified scan bodies will be done by direct intraoral scan technique. For group (II): For each patient, two final impressions will be made a) Final impression will be done by conventional one-step impression technique.For the same patient another final impression using subtractive modified scan bodies will be done by direct intraoral scan technique. Conventional impression for both groups will be poured into stone cast with multiunit abutments analogues, then scanned to be as a reference file for each patient.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040385
- Sponsor's protocol ID
- M0203023RP
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Geometric Modifications of Implant Scan Bodies Compared to Conventional Transfer Techniques on Passivity of Mandibular All on Four Restorations
- ClinicalTrials.gov ID
- NCT06040385
- Acronym / sponsor ID
- M0203023RP
- Conditions
- Prosthesis Durability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 16 Feb 2025 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical study will be the effect of geometric modifications of implant scan bodies compared to conventional transfer techniques on passivity of all on four mandibular restorations
Detailed description
The aim of this study will be the effect of geometric modifications of implant scan bodies compared to conventional transfer techniques on passivity of all on four mandibular restorations.
Evaluation method:
The trueness of the final impression and the passivity of the final prosthesis will be evaluated by two methods:
Invitro evaluation For each patient in every group, the standard tessellation language (STL) files of scanned impressions will be superimposed on the reference file to determine the 3D surface, linear, and angular position analysis.
The STL files for both frameworks will be superimposed on the reference file to determine the passivity.
In vivo (Clinical) evaluation Radiographic evaluation using long cone parallel technique will be done for the framework after 6 month (T6) after one year (T12), and after 18 month (T18) from insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- For group (I): For each patient, two final impressions will be made a) Final impression will be done by conventional one-step impression technique.For the same patient, another final impression using unmodified scan bodies will be done by direct intraoral scan technique. For group (II): For each patient, two final impressions will be made a) Final impression will be done by conventional one-step impression technique.For the same patient another final impression using subtractive modified scan bodies will be done by direct intraoral scan technique. Conventional impression for both groups will be poured into stone cast with multiunit abutments analogues, then scanned to be as a reference file for each patient.
| Arm | Type | Receives |
|---|---|---|
| • Group I (control group) | Active comparator | Device: Implant supported hybrid prosthesisFinal impression will be done by conventional one-step impression technique. For the same patient, another final impression using unmodified scan bodies will be done by direct intraoral scan technique. |
| • Group II (Test Group) | Active comparator | Device: Implant supported hybrid prosthesisFinal impression will be done by conventional one-step impression technique. For the same patient another final impression using subtractive modified scan bodies will be done by direct intraoral scan technique |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. All selected patients will have four implants placed in the mandibular interforaminal region according to all -on -four concept.
- 2. All selected patients have a healthy mucosa and with no clinical complications.
- 3. All patients are cooperative and approve the proposed treatment protocol.
Key exclusion criteria (1 listed)
- 1. Patients who reject to participate in the study. 2. Patients who need implant placement as a result of previous implant failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant supported hybrid prosthesisFor each patient, implant supported mandibular hybrid prosthesis will be fabricated digitally. Frameworks will be tried in patient's mouth, scanned intraorally by intraoral scanner (IOS). | Device | • Group I (control group), • Group II (Test Group) |
Primary outcome
passivity of the prosthesis
Time frame: one year
Radiographic evaluation using long cone parallel technique will be done for the framework
trueness of final impressions
Time frame: one year
For each patient in every group, the standard tessellation language (STL) files of scanned impressions will be superimposed on the reference file to determine the 3D surface, linear, and angular position analysis
1 secondary outcome
patient satisfaction
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant supported hybrid prosthesis in people with Prosthesis Durability, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
passivity of the prosthesis (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.